ISPE Updates

Do you want to shape the future and help lead ISPE?

Consider applying to serve on the board of directors starting August 2022. The ISPE Nominating Committee is seeking candidates for election to the Society's Board of Directors for a 3-year term. 

Learn more here
Deadline: December 31, 2021

Urgent Call for Comments: ISPE comments to RWD: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biologic Products

ISPE's Real-World Evidence Task Force's Regulatory Decision-making Subgroup has prepared comments for submission to the FDA. Per ISPE policy 1.7.2 Circumstances of Public Importance and/or Urgency, (see Policy Manual here), ISPE's Public Policy Committee chair has agreed the urgent review of these comments.
Learn more and access the comments paper here
Deadline: Oct 31, 11:00 pm EDT

Call for ISPE Fellowship (FISPE) Applications. Deadline December 15.

The ISPE Board of Directors established the membership category ISPE Fellow to recognize and advance leadership in the Society. This membership category is awarded upon recommendation by a committee of peers. Learn more and apply for an ISPE Fellowship here.

Urgent Call for Comments on Assessing Feasibility of Using Electronic Health Records and Medical Claims Data for Regulatory Decisions

On September 29, 2021, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry on use of electronic health records (EHR) and medical claims to support regulatory decisions on drug and biological products.

Learn more and access the manuscript here
Deadline: October 24, 2021, 11:00 pm EST

Call for comments A road map for peer review of real-world evidence studies on safety and effectiveness of treatments

Consistent with Section 1.7.1 Endorsement of documents as ISPE Public Policy (see ISPE Policy Manual) the Public Policy Committee has approved a call for member comments for the paper linked below.
Learn more and access the manuscript here
Deadline: October 25, 2021 EOB

Congratulations to all our 2021 ICPE Award Winners

View ICPE awards video here

Call for Topics for ICPE 2022

ISPE is planning the ICPE 2022 meeting and we want your suggestions for plenary and hot topic speakers. View more information here

Upcoming Webinars:

Interested in presenting a webinar? Submit a webinar proposal here